HRPP Policies & Forms Chapter Two Created/Revised for AAHRPP June 1, 2007

HRPP Policies & Forms HRPP Policies & Forms Chapter TwoChapter Two

Created/Revised for AAHRPPCreated/Revised for AAHRPP

June 1, 2007June 1, 2007

REVISED POLICIESREVISED POLICIES

Revised PolicyRevised PolicySOP 202SOP 202Management of IRBManagement of IRB

The performance of the IRB Chairs, Vice Chairs, The performance of the IRB Chairs, Vice Chairs, and IRB Members shall be evaluated on an annual and IRB Members shall be evaluated on an annual basis. basis.

This periodic evaluation is conducted to assess This periodic evaluation is conducted to assess performance taking into consideration, completion performance taking into consideration, completion of education requirements, attendance, of education requirements, attendance, preparedness, knowledge and abilities in applying preparedness, knowledge and abilities in applying the ethical principles and regulations governing the ethical principles and regulations governing human research, and knowledge of IRB policies human research, and knowledge of IRB policies and procedures.and procedures.

Newly Created FormsNewly Created Forms

Chair/Vice Chair Evaluation FormChair/Vice Chair Evaluation Form

Board Member Evaluation FormBoard Member Evaluation Form

Revised PolicyRevised PolicySOP 403SOP 403

Initial Review - Criteria for IRB ApprovalInitial Review - Criteria for IRB Approval

The IRB shall evaluate proposed research for scientific The IRB shall evaluate proposed research for scientific or scholarly validity based on the following:or scholarly validity based on the following:

Whether the research uses procedures consistent Whether the research uses procedures consistent with sound research design, which did not with sound research design, which did not unnecessarily expose participants to risk.unnecessarily expose participants to risk.

Whether the research is designed to answer the Whether the research is designed to answer the proposed question.proposed question.

The importance of the knowledge reasonably The importance of the knowledge reasonably expected to result from the research.expected to result from the research.

Revised PolicyRevised Policy

SOP 404 SOP 404

Continuing ReviewContinuing ReviewAs an outcome of continuing review, the IRB may As an outcome of continuing review, the IRB may require that the research be suspended or require that the research be suspended or terminated as per SOP 411 Suspension or terminated as per SOP 411 Suspension or Termination of IRB Approval.Termination of IRB Approval.

As an outcome of continuing review, the IRB may As an outcome of continuing review, the IRB may require that any significant new findings that arise require that any significant new findings that arise from the continuing review process and that might from the continuing review process and that might relate to participants’ willingness to continue relate to participants’ willingness to continue participation will be provided to participants.participation will be provided to participants.


SOP 407SOP 407

Unanticipated Problems Involving Risks toUnanticipated Problems Involving Risks to

Participants or Others & Participants or Others & Protocol DeviationsProtocol Deviations

When a deviation occurs, the Investigator completes When a deviation occurs, the Investigator completes the protocol deviation form.the protocol deviation form.

The Investigator determines if the protocol deviation The Investigator determines if the protocol deviation meets the definition of an unanticipated problem meets the definition of an unanticipated problem according to the criteria indicated on the deviation according to the criteria indicated on the deviation form and submits the form to the IRB.form and submits the form to the IRB.

SOP 407SOP 407

If the IRB Chair determines that the protocol If the IRB Chair determines that the protocol deviation is an unanticipated problem involving risks deviation is an unanticipated problem involving risks to participants or others or resulted from serious or to participants or others or resulted from serious or continuing noncompliance, the deviation report will continuing noncompliance, the deviation report will be reviewed at an IRB meeting.be reviewed at an IRB meeting.

If the IRB Chair determines the protocol deviation If the IRB Chair determines the protocol deviation does not meet the criteria of an unanticipated does not meet the criteria of an unanticipated problem, the deviation will be reviewed by the problem, the deviation will be reviewed by the expedited procedure.expedited procedure.

Revised Form Revised Form

Protocol Deviation Report FormProtocol Deviation Report Form


SOP 502G SOP 502G Emergency Use of FDA Regulated ProductsEmergency Use of FDA Regulated Products

Planned emergency researchPlanned emergency research is defined as is defined as planned research involving a life-threatening planned research involving a life-threatening emergency where the requirement to obtain emergency where the requirement to obtain prospective informed consent has been waived.prospective informed consent has been waived.

The research plan must be approved in advance The research plan must be approved in advance by the FDA or DHHS and the IRB, and project, as by the FDA or DHHS and the IRB, and project, as well as its results, are publicly disclosed to the well as its results, are publicly disclosed to the community in which the research is conducted.community in which the research is conducted.

SOP 502GSOP 502G

The IRB The IRB will notwill not review and waive the review and waive the requirement to obtain consent for requirement to obtain consent for planned emergency research. planned emergency research. Therefore, no planned emergency Therefore, no planned emergency research can be conducted at OU.research can be conducted at OU.


601601IRB Communication and NotificationIRB Communication and Notification

Notification to Institutional Offices and Officials Notification to Institutional Offices and Officials

The HSC IRB shall notify the HSC Office of The HSC IRB shall notify the HSC Office of the Provost, Senior Vice President and the Provost, Senior Vice President and Provost as Institutional Official of IRB Provost as Institutional Official of IRB findings and actions. The Institutional findings and actions. The Institutional Official shall receive a copy of the IRB Official shall receive a copy of the IRB meeting minutes for each IRB.meeting minutes for each IRB.

SOP 601SOP 601

Questions, Concerns and Suggestions Regarding Questions, Concerns and Suggestions Regarding thethe

Human Research Participant Protection ProgramHuman Research Participant Protection Program

Investigators can direct questions, concerns and Investigators can direct questions, concerns and suggestions regarding the Human Research suggestions regarding the Human Research Participant Protection Program to the HRPP Director. Participant Protection Program to the HRPP Director.

Investigators can direct questions, concerns and Investigators can direct questions, concerns and suggestions regarding the Human Research suggestions regarding the Human Research Participant Protection Program that cannot be Participant Protection Program that cannot be satisfactorily addressed by the HRPP Director to the satisfactorily addressed by the HRPP Director to the Director of Compliance or the Institutional Official. Director of Compliance or the Institutional Official.


SOP 70lSOP 70lConsent Process & DocumentationConsent Process & Documentation Waiver of Documentation of Informed Waiver of Documentation of Informed

ConsentConsent

If documentation of informed consent is If documentation of informed consent is waived, thewaived, the Investigator will ask whether Investigator will ask whether the participant wants documentation the participant wants documentation linking the participant with the research, linking the participant with the research, and the participant’s wishes will govern.and the participant’s wishes will govern.

SOP 701SOP 701

If the IRB waives the requirement of If the IRB waives the requirement of documentation of informed consent, the IRB documentation of informed consent, the IRB may require the investigator to provide a may require the investigator to provide a written statement of the research to the written statement of the research to the participant. participant.

The IRB shall review and approve the written The IRB shall review and approve the written statement prior to the investigator providing the statement prior to the investigator providing the statement to the participant. statement to the participant.

The consent form reviewed and approved by The consent form reviewed and approved by the IRB may also serve as the written the IRB may also serve as the written statement. statement.

SOP 701SOP 701

Legally Authorized RepresentativeLegally Authorized Representative

For research conducted For research conducted outside of Oklahomaoutside of Oklahoma, , individuals who meet the definition of a legally individuals who meet the definition of a legally authorized representative are those individuals as authorized representative are those individuals as described under the applicable law of the jurisdiction described under the applicable law of the jurisdiction in which the research will be conducted. in which the research will be conducted.

If recruiting a participant from a legally authorized If recruiting a participant from a legally authorized representative the investigator must report this representative the investigator must report this category of participant on the IRB application and category of participant on the IRB application and provide to the IRB the definition of legally authorized provide to the IRB the definition of legally authorized representative for the applicable jurisdictionrepresentative for the applicable jurisdiction..


SOP 901 SOP 901 Quality ImprovementQuality Improvement

Investigator-initiated studies, where the Investigator-initiated studies, where the investigator holds an IND/IDE, are the investigator holds an IND/IDE, are the primary targets of routine evaluation. primary targets of routine evaluation. When assuming the role of the sponsor, the When assuming the role of the sponsor, the investigator is evaluated to ensure investigator is evaluated to ensure compliance with the additional regulatory compliance with the additional regulatory requirements as outline in requirements as outline in SOP 802 Sponsor Responsibilities SOP 802 Sponsor Responsibilities and good and good manufacturing practice.manufacturing practice.

SOP 901SOP 901

The investigator is required to submit an The investigator is required to submit an annual report to the FDA and is notified by annual report to the FDA and is notified by the IRB sixty days in advance of its due the IRB sixty days in advance of its due date. Compliance with this requirement is date. Compliance with this requirement is monitored by the IRB staff via the monitored by the IRB staff via the continuing review application.continuing review application.

SOP 901SOP 901

Observation of the Consent ProcessObservation of the Consent Process

The IRB has the authority to observe, or have a The IRB has the authority to observe, or have a third party observe, the informed consent process third party observe, the informed consent process of research it has approved, and to verify that the of research it has approved, and to verify that the study is being conducted as required by the IRB study is being conducted as required by the IRB and within the institutional policies and procedures and within the institutional policies and procedures and site-specific procedures, as appropriate. and site-specific procedures, as appropriate.

Before the IRB or third party observes the consent Before the IRB or third party observes the consent process, verbal consent of the participant may be process, verbal consent of the participant may be sought.sought.

SOP 901SOP 901

The IRB may determine it is necessary to observe theThe IRB may determine it is necessary to observe the

informed consent process in order to provide additionalinformed consent process in order to provide additional

protections and may conduct informed consentprotections and may conduct informed consent

observations in the following situations:observations in the following situations: Non-compliance per SOP 903, Non-compliance per SOP 903, Unanticipated problems involving risks to Unanticipated problems involving risks to

participants or others per SOP 407, participants or others per SOP 407, Protocol deviations as per SOP 407,Protocol deviations as per SOP 407, Participant complaints, orParticipant complaints, or or any other situation the IRB deems appropriate or any other situation the IRB deems appropriate

where additional protections are necessary.where additional protections are necessary.

Consent ObservationConsent Observation

Informed Consent Observation CheckliInformed Consent Observation Checklistst

SOP 901SOP 901

IRB Internal Evaluations/Improvement IRB Internal Evaluations/Improvement PlanPlan

The HRPP shall measure and improve the The HRPP shall measure and improve the program’s effectiveness, quality, and program’s effectiveness, quality, and compliance with organizational policies compliance with organizational policies and procedures and applicable federal, and procedures and applicable federal, state, and local laws.state, and local laws.

SOP 901SOP 901

IRB Internal EvaluationsIRB Internal Evaluations

Improvements to the HRPP program shall be Improvements to the HRPP program shall be implemented based upon measures identified implemented based upon measures identified through routine evaluations of the program. through routine evaluations of the program. These improvements include education programs, These improvements include education programs, IRB member and staff training, revising Policies IRB member and staff training, revising Policies and Procedures, and form changes.and Procedures, and form changes.

The improvements shall be monitored and The improvements shall be monitored and measured to determine effectiveness. If measured to determine effectiveness. If necessary, additional improvements shall be necessary, additional improvements shall be implemented.implemented.

VA-Specific RevisionsVA-Specific Revisions


Consent RequirementConsent Requirement

If someone other than the investigator If someone other than the investigator will be conducting the interview and will be conducting the interview and obtaining consent, the investigator must obtaining consent, the investigator must formally delegate the responsibility to an formally delegate the responsibility to an individual who has received appropriate individual who has received appropriate training to perform this activity.training to perform this activity.


For VA research the legally authorized representative is For VA research the legally authorized representative is

defined as the following persons in the following order defined as the following persons in the following order of of

priority:priority:

Health-care agent.Health-care agent. Legal guardian or special guardian.Legal guardian or special guardian. A close relative of the patient eighteen years of age A close relative of the patient eighteen years of age

or older, in the following priority: spouse, adult child or older, in the following priority: spouse, adult child (18 years or older), parent, sibling (18 years or (18 years or older), parent, sibling (18 years or older), grandparent, adult grandchild (18 years or older), grandparent, adult grandchild (18 years or older), close friend (18 years or older). older), close friend (18 years or older).


Exempt Research Category #2Exempt Research Category #2

Research involving the use of educational tests Research involving the use of educational tests (cognitive,(cognitive,

diagnostic, aptitude, achievement), survey procedures,diagnostic, aptitude, achievement), survey procedures,

interview procedures, or observation of public behavior, interview procedures, or observation of public behavior,

unlessunless:: Information obtained is recorded in such a manner Information obtained is recorded in such a manner

that human participants can be identified, directly that human participants can be identified, directly or through identifiers linked to the subjects; and or through identifiers linked to the subjects; and


Exempt Research Category #2Exempt Research Category #2

Any disclosure of the human participants' Any disclosure of the human participants' responses outside the research could responses outside the research could reasonably place the participants at risk of reasonably place the participants at risk of criminal or civil liability or be damaging to the criminal or civil liability or be damaging to the participants' financial standing, employability, participants' financial standing, employability, or reputationor reputation. . NOTE: The Department of NOTE: The Department of Veterans Affairs (VA) also includes loss of Veterans Affairs (VA) also includes loss of insurability in this category.insurability in this category.


Continuing ReviewContinuing Review

For VA research that expires because For VA research that expires because continuing review is not completed the IRB shall continuing review is not completed the IRB shall notify the sponsoring agency, private sponsor, notify the sponsoring agency, private sponsor, Office of Research and Development, Office of Office of Research and Development, Office of Research Oversight, or other Federal agencies, Research Oversight, or other Federal agencies, as appropriate.as appropriate.


Drug Dispensing & AccountabilityDrug Dispensing & Accountability

The investigator shall provide the pharmacy The investigator shall provide the pharmacy with a signed copy of the VA Form 10-1086 to with a signed copy of the VA Form 10-1086 to document each participant’s consent to document each participant’s consent to participate in the study. participate in the study.

The Investigator shall inform the Chief, The Investigator shall inform the Chief,

Pharmacy Service, and the R&D Committee Pharmacy Service, and the R&D Committee when the research has been terminated.when the research has been terminated.

Sponsored Research Sponsored Research AgreementsAgreements

Contracts shall:Contracts shall:

Identify who is responsible to provide and pay Identify who is responsible to provide and pay for medical care for research-related injuries.for medical care for research-related injuries.

Include language stating the sponsor will Include language stating the sponsor will promptly notify the organization of any study promptly notify the organization of any study results or findings that could affect the conduct results or findings that could affect the conduct of the study, participant safety, participant’s of the study, participant safety, participant’s willingness to continue in the study, or the IRB’s willingness to continue in the study, or the IRB’s approval to continue the study.approval to continue the study.

REVISED FORMSREVISED FORMS

Revised FormsRevised Forms

New Research Project ApplicationNew Research Project Application

Determination of Human Research WorkshDetermination of Human Research Worksheeteet

Revised Consent TemplateRevised Consent Template

Consent TemplateConsent Template

Revised Reviewer ChecklistsRevised Reviewer Checklists

New Study Reviewer ChecklistNew Study Reviewer Checklist– Full Board ReviewFull Board Review– Expedited ReviewExpedited Review– ExemptExempt

Continuing Review ChecklistContinuing Review Checklist VA CriteriaVA Criteria Waiver of Consent Waiver of Consent

Effective DateEffective Date

June 1, 2007June 1, 2007

Documents

HRPP Policies & Forms Chapter Two Created/Revised for AAHRPP June 1, 2007